Kornimate/medical-research-clean huggingface dataset:
olmesartan medoxomil in diabetes mellitus

Conditions: Diabetes Mellitus, Type 2; Cardiovascular Disease; Kidney Disease

Summary: this is a study in diabetic patients with at least one additional cardiovascular risk factor and normoalbuminuria prior to randomization.


Eligibility criteria:
inclusion criteria: * diabetes mellitus type 2, defined as fasting blood glucose of greater than or equal to 126 mg/dl; * presence of at least one of the following cardiovascular risk factors: 1. total cholesterol greater than 200 mg/dl or statin treatment, 2. high density lipoprotein (hdl) less than 40 mg/dl, 3. triglycerides greater than 150 mg/dl and less than 400 mg/dl, 4. blood pressure greater than or equal to 130/80 mmhg, 5. body mass index (bmi) greater than 28 kg/m2, 6. waist circumference greater than 102 cm for men and greater than 88 cm for women, 7. smoking of more than 5 cigarettes a day; * normoalbuminuria at screening exclusion criteria: * severe uncontrolled hyperlipidemia; * documented renal and/or renal-vascular disease; * myocardial infarction, stroke or myocardial revascularization within the last 6 months; * history of alcohol and/or drug abuse; * allergic reaction, lack of response or contraindication to angiotensin receptor blockers (arbs); * current treatment with an arb or angiotensin converting enzyme (ace) inhibitor

Keywords: microalbuminuria
functional outcomes following anal cancer treatment

Conditions: Anal Cancer

Summary: anal cancer is treated with chemoradiotherapy- combined chemotherapy and radiotherapy. this is very successful (75% long term survival). during the course of the radiotherapy, other organs in the pelvis may be damaged. this can lead to long-term problems with possible changes to the skin, bowels with diarrhoea and incontinence problems, bladder shrinkage and incontinence of urine, sexual problems including impotence and ejaculatory problems, or pain during sexual intercourse with vaginal dryness and shrinkage. patients should be offered help with these side effects. at present, there is very little information on the effect treatment has on a patient's quality of life, making it difficult to judge if new treatment methods are better. this project will measure quality of life from the patient's perspective after treatment for anal cancer. it will also gather preliminary data on quality of life after the introduction of a new technique for more precise 3d-targeting of radiotherapy beams at the cancer, called imrt.


Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * male or female, aged 18 years or above. * squamous cell or basaloid carcinoma of the anal canal exclusion criteria: * adenocarcinoma, melanoma, lymphoma, sarcoma or other malignancy of anal canal * any synchronous or metanchronous pelvic malignancy of non-anal origin (eg. prostatic, genital tract) * unable to complete questionnaire

Keywords: anal cancer squamous cell cancer radiotherapy chemoradiotherapy conformational radiotherapy intensity modulated radiation therapy imrt
arda software for the detection of mtmdr

Conditions: Diabetic Retinopathy

Summary: this is a multicenter, observational study with primary endpoints to determine the sensitivity and specificity of two investigational software devices that detect the presence of more than mild diabetic retinopathy (mtmdr) in healthcare settings.


Eligibility criteria:
inclusion criteria: 1. documented diagnosis of type i or type ii diabetes mellitus: meet the criteria established by either the world health organization (who) or the american diabetes association (ada) 2. age 22 or older 3. understand the study and volunteer to sign the informed consent exclusion criteria: 1. self-reported visual symptoms and persistent blurred vision (greater than 24 hours); including vision loss that cannot be corrected (e.g. with eye glasses). 2. diagnosed with macular edema, any known retinopathy, radiation retinopathy, or retinal vein occlusion. 3. history of laser treatment of the retina or injections into either eye, or any history of retinal surgery. 4. scheduled to undergo the following surgeries before completion of the study imaging: cataract surgery (including any related follow-up procedures) or vitrectomy. 5. currently participating in an interventional study. 6. participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation, etc.). 7. participant is contraindicated for imaging by fundus imaging system used in the study; e.g. 1. participant is hypersensitive to light (side effect of medication or due to unknown etiology) 2. participant has undergone photodynamic therapy (pdt) 3. previous issues with dilation (angle closure, inability to dilate, allergy to dilation drops). 8. known pregnancy or possibility of pregnancy
the effect of standardizing procedures for sc injections of lmwh on patients with cvd

Conditions: CVD - Cardiovascular Disease; Bruise; Pain

Summary: improper subcutaneous administration of lmwh may cause complications at the injection site. standardized protocol for subcutaneous lmwh injections in patient with cardiovascular diseases is warranted to ensure consistent best practices in clinical settings.

this study examines the effect of standardized protocol in reducing complications for patients with cardiovascular disease.

Eligibility criteria:
inclusion criteria: * patients who are in cardiac care units suffering from cardiovascular diseases prescribed with lmwh injections two times per day * chinese exclusion criteria: * cognitively impaired * unconscious * refuse to participate

Keywords: lmwh injection
low dose rosuvastatin plus ezetimibe versus high-dose rosuvastatin in ami

Conditions: Myocardial Infarction; Statin Adverse Reaction; HMG-CoA Reductase Inhibitor Toxicity

Summary: combination therapy of rosuvastatin 5mg and ezetimibe 10 mg showed similar achievement rate in decreasing ldl cholesterol level by 50% as single use of rosuvastatin 20 mg. this trial aims to prove non-inferiority of concomitant usage of low dose rosuvastatin and ezetimibe among patients with acute myocardial infarction who went through percutaneous coronary intervention at decreasing major adverse cardiac events compared to the efficacy of single use of high dose rosuvastatin.

improve-it (improved reduction of outcomes: vytorin efficacy international trial) study showed that even when statin is not used as a treatment the rate of decrease of ldl cholesterol is correlated to the risk of heart disease. yet whether concomitant use of ezetimibe and statin will have similar degree of clinical efficacy as single use of high dose statin in decreasing ldl cholesterol level needs further examination.

Eligibility criteria:
inclusion criteria: 1. adults aged 19 and up 2. patients diagnosed with myocardial infarction (both st segment elevation and non-st segment elevation) who were treated with percutaneous coronary intervention (myocardial infarction defined as in the 4th universal definition of myocardial infarction) 3. for female patients who are of childbearing age, subjects that agreed on taking mandatory pregnancy test 4. patients who agreed and signed on the informed consent form exclusion criteria: 1. patients with life expectancy of a year or less due to malignancy 2. patients with chronic liver disease 3. patients with sensitivity to active ingredient of the research drugs (ezetimibe and/or rosuvastatin) or patients who are prohibited to take ezetimibe and/or rosuvastatin. 4. pregnant and/or breastfeeding 5. female patients who are unable to use any means of contraception 6. patients receiving hemodialysis, peritoneal dialysis patients and/or kidney transplant patients, due to end stage renal disease 7. patients who participated in other clinical trial(s) within 3 months from the screening (except non-interventional observational study) 8. patients considered inappropriate for the study for any other reason(s) by the inspector(s)
gemcitabine and oxaliplatin in treating patients with metastatic cancer

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. giving more than one drug (combination chemotherapy) may kill more cancer cells. purpose: this phase ii trial is studying how well giving gemcitabine together with oxaliplatin works in treating patients with metastatic cancer who cannot receive anthracycline or taxane therapy.

objectives: primary * determine the objective response rate in patients with metastatic cancer not amenable to anthracycline or taxane therapy treated with gemcitabine hydrochloride and oxaliplatin. secondary * determine the clinical benefit and tolerability of this regimen in these patients. * determine the progression-free and overall survival of patients treated with this regimen. outline: this is an open-label, multicenter study. patients receive gemcitabine hydrochloride iv over 100 minutes on day 1 and oxaliplatin iv over 2 hours on day 2. treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed periodically. projected accrual: a total of 45 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed cancer * metastatic disease * measurable metastatic disease ≥ 1 cm by spiral ct scan and/or cutaneous lesion ≥ 2 cm * not a candidate for anthracycline or taxane chemotherapy * no brain metastases patient characteristics: * ecog performance status (ps) 0-2 or karnofsky ps 60-100% * life expectancy \> 12 weeks * neutrophil count \> 1,000/mm\^3 * platelet count \> 100,000/mm\^3 * alkaline phosphatase \< 5 times upper limit of normal (uln) * bilirubin \< 1.5 times uln * creatinine \ 30 ml/min * sgot and sgpt \< 3 times uln (5 times uln if liver metastases present) * no pre-existing neuropathy * not pregnant or nursing * no uncontrolled hypercalcemia * no familial, social, geographical, or psychological condition that would preclude study treatment * no other malignancy that is not considered cured prior concurrent therapy: * no prior chemotherapy for metastatic disease, including anthracyclines or taxanes * prior hormonal therapy allowed

Keywords: unspecified adult solid tumor, protocol specific
transpyloric versus gastric feeding in bronchopulmonary dysplasia

Conditions: Bronchopulmonary Dysplasia; Gastroesophageal Reflux

Summary: the goal of this clinical trial is to learn if transpyloric tube feeding (feeding directly into the small intestine) versus gastric tube feeding tolerably and effectively reduces gastroesophageal reflux in infants born premature who have been diagnosed with bronchopulmonary dysplasia. the main questions this trial aims to answer are: does transpyloric as compared to gastric tube feeding result in differences in the amount of experienced hypoxemia (low oxygen level in the blood) or serious adverse events? does transpyloric as compared to gastric tube feeding reduce the frequency and severity of gastroesophageal reflux (ger) measured using 24 hour esophageal ph-multichannel intraluminal impedance (ph-mii) monitoring? participants will: undergo pre-trial 24 hour ph-mii monitoring to determine baseline severity of ger. be randomly assigned to receive transpyloric or gastric tube feeding for 2 weeks. undergo repeat ph-mii at the end of the 2 week trial to assess for change in ger. undergo continuous pulse oximetry to record level of hypoxemia during the 2 week trial. undergo saliva and airway (if supported by a breathing tube) fluid collection to measure biomarkers of ger. be monitored clinically for possible adverse events.


Eligibility criteria:
inclusion criteria: 1. birth \<32 weeks' gestation 2. current postmenstrual age of 36-65 weeks 3. grade 2-3 bronchopulmonary dysplasia (bpd: treatment with positive airway pressure at 36 weeks' pma) or grade 1 bpd (treatment with ≤2l/min flow nasal cannular at 36 weeks' pma) with subsequent need for prolonged positive airway pressure and full enteral tube feedings 4. treatment with positive airway pressure (high flow nasal cannula, non-invasive positive airway pressure, or invasive ventilation) at enrollment (4) full gastric tube feedings (≥100ml/kg/d) at the time of enrollment (5) parental consent to participate note: at least 20 infants receiving invasive ventilation will be enrolled to enable endotracheal biomarker testing. exclusion criteria: 1. transpyloric feedings received within 7d of enrollment 2. use of a gastric acid suppression, gi promotility drug, or caffeine within 7d of enrollment 3. history of gastrostomy tube placement, gastric fundoplication, or bowel resection resulting in short gut with contraindication to transpyloric feeding 4. plan to wean off positive airway pressure (for non-intubated subjects) or to be extubated to non-invasive support (for subjects receiving invasive ventilation) within the 2wk trial 5. known intolerance to transpyloric feeding 6. persistent \>20% endotracheal tube leak (for intubated subjects only) 7. active treatment with an investigational therapy as part of another interventional trial 8. severe congenital or genetic abnormality that adversely affects gi or cardiopulmonary function
a post-marketing surveillance to assess safety of abiraterone acetate (zytiga) in indian participants with metastatic, castration resistant prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate the safety of abiraterone acetate in indian participants with metastatic, castration-resistant prostate cancer who have been prescribed abiraterone acetate as per locally approved prescribing information.

this is a prospective (the participants are identified and then followed forward in time for the outcome of the study), multicenter (when more than one hospital or medical school team work on a medical research study), post-marketing surveillance (\[pms\], surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale) study. the study will consist of screening and enrolment visit (day 1) and follow-up period (12 months). for each participant, the follow-up visits will be conducted as per routine clinical practice at month 3, 6 and 9. the end-of-study (eos) visit will be conducted after the completion of 12-months abiraterone acetate (zytiga) and a telephonic follow-up will be conducted 30 days after the eos visit. the total duration of the study will be 13 months. participants receiving abiraterone acetate as per locally approved prescribing information will be enrolled in the pms. the use of abiraterone acetate will follow dosing and frequency stipulated in the locally approved prescribing information. participants will be monitored during treatment of abiraterone acetate and up to 30 days post treatment for collection of adverse events. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * participants with established diagnosis of metastatic castration-resistant prostate carcinoma * being newly initiated on zytiga treatment (abiraterone acetate tablets 250 mg) based on independent clinical judgment of treating physicians as per locally approved prescribing information * willing to provide written informed consent indicating that they understand the purpose and are willing to participate in the post-marketing surveillance (pms) exclusion criteria: * participants who are not eligible to receive zytiga as per the locally approved prescribing information * participants participating or planning to participate in any interventional drug trial during the course of this pms

Keywords: post-marketing surveillance abiraterone acetate zytiga
evaluation of lithium as a glycogen-synthase-kinase-3 (gsk-3) inhibitor in mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: the project is designed to generate critical information to design and justify a robust trial on lithium prevention of the onset of alzheimer's disease (ad). lithium exerts and inhibitory effect on glycogen synthase kinase 3 (gsk-3) a brain biomarker of neuroprotection. the study consists of 3 phases: 1. phase 1 investigates rats to establish a reliable method to measure brain biomarker activity levels from blood biomarker activity. 2. phase 2 will determine whether the gsk3 enzyme activity is significantly different in subjects with mci compared to normal individuals. 3. phase 3 investigates patients with mci taking lithium to establish the minimum lithium dose required to inhibit the activity of gsk-3.

lithium has been used for decades to treat bipolar affective disorder. some of its therapeutic benefits are through the inhibition of the enzyme glycogen synthase kinase-3 (gsk-3). gsk3 activity is associated with the development of several aspects of ad and thus lithium can regulate an enzyme linked to ad development. as an important step towards designing a clinical trial to investigate the potential of lithium for ad prevention the investigators propose to establish the minimum dose of lithium needed to block gsk3 in people with mild cognitive impairment (mci), a high-risk condition for progression to ad. the study will establish whether gsk3 activity is altered in mci and monitor lithium regulation of gsk3 biomarkers in this population. at the same time the study will investigate how gsk3 measured in blood relates to gsk3 activity in the brain in a small animal study. in further preparation for a future large scale trial, this pilot study will generate technical data to develop the technique of using magnetic resonance spectroscopy (mrs) as a biomarker to detect the earliest brain changes of ad. recruitment will be shared between the two sites for this study, dundee and oxford. the study will involve 12 patients with mci and 12 controls, who will be asked for two sets of blood tests, and 20 patients with mci who consent to take lithium who will be asked for blood tests at regular intervals. for all participants the study period is 12 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of mild cognitive impairment (mci). exclusion criteria: * previous hypersensitivity to lithium or other contraindication to lithium carbonate priadel (see most recent smpc), dementia diabetes bmi \ 30 rheumatoid arthritis and autoimmune inflammatory disorders currently taking nsaids moderate renal failure (defined in bnf by ggfr \<60 ml/minute/1.73m2) or severe renal failure (defined in bnf by egfr \<29 ml/minute/1.73m2 addison's disease, brugada syndrome (or family history of brugada syndrome), cardiac insufficiency, congestive cardiac failure, epilepsy, suicidality incapacity to consent currently prescribed lithium participation in another clinical trial of an investigational medicinal product (imp) in the last 28 days. uncontrolled serious concomitant physical illness
mechanisms of treatment effects using cultured, allogeneic mesenchymal stromal stem cells (mscs) in knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: the goal of this clinical trial is to pharmacologically evaluate the effects of culturued allogeneic umbilical cord blood-derived mesenchymal stromal stem cell (ucb-mscs) in the treatment of end-stage knee osteoarthritis (kellgren-lawrence grade 4) with the analysis of soluble biomarkers and expression of key genes, as well as the evaluation of clinical outcomes with patient-reported outcome measures (proms) and recording of potential complications. patients will be randomized in the intervention and control groups. in both groups, the knee aspiration will be performed 4-6 weeks prior to the knee arthroplasty to analyse baseline synovial fluid characteristics. the intervention group will receive the injection of ucb-mscs. all patients will complete proms questionnaires and maintain a pain diary on visual analogue scale (vas) at home until the surgery. on the day of admission to hospital for knee arthroplasty, the same questionnaires will be administered again. during the operative procedures, the samples of synovial fluid, synovial membrane and resected cartilage will be obtained and analysed afterwards. it is anticipated that the study results will contribute to elucidate the mechanisms of action of mscs in the treatment of knee osteoarthritis.


Eligibility criteria:
inclusion criteria: * patients with end-stage (kellgren-lawrence) knee osteoarthritis scheduled for knee arthroplasty * osteoarthritis of primary or post-traumatic etiology exclusion criteria: * secondary arthritis of other etiology * rheumatic diseases * uncontrolled metabolic disorders * crystalopathies * coagulopathy * anticoagulant therapy * heart failure * renal failure * other conditions that may affect immune response or pose additional risk during cell application

Keywords: knee osteoarthritis mesenchymal stem cells allogeneic
adhesive performance of glass ionomer and resin based adhesive systems: a 3 years prospective clinical evaluation

Conditions: Dental Leakage

Summary: this study aimed to clinically evaluate the 3-years clinical performance of glass ionomer and resin based adhesive systems in class v restorations.

the formulated null hypothesis was that there is no significant difference in the clinical performances between glass ionomer and resin based adhesive systems in class v restorations for 3-years. the research question was as follows: do glass ionomer adhesives in class v restorations present better clinical performances than resin based adhesive systems according to the modified united states public health service (modified-usphs) criteria?

Eligibility criteria:
inclusion criteria: 1. patients with primary caries involving cervical surface only with icdas 2 and 3. 2. patients with normal and full occlusion. 3. patients with tooth gives positive response to testing with an electric pulp tester. 4. patients must have a good oral hygiene. 5. patients with opposing teeth should be natural with no restorations. exclusion criteria: 1. high caries risk patients with extremely poor oral hygiene. 2. patients involved in orthodontic treatment or periodontal surgery. 3. patients with periodontally involved teeth (chronic periodontitis). 4. patients with heavy bruxism habits and clenching. 5. patients with abutments should be excluded.

Keywords: resin composite randomized clinical trial operative dentistry
the effect of 25-oh-vitamin-d3 substitution in patients with malignant and immune-hematologic diseases

Conditions: Chronic Lymphoid Leukemia

Summary: recent data have shown that the inadequate vitamin d status plays a role in the manifestation of the haematologic tumors and serum vitamin d level has a prognostic role also as it determines the tumor mortality. but data have not proved a causal relationship between the inadequate vitamin d status and the unfavourable outcomes so far. it is also still unknown, whether the normalization of vitamin d status in patient with vitamin d inadequacy is able to improve the prognosis and survival. in this study the investigators examine the role of the adequate vitamin d substitution in the improvement of the outcomes of haematologic disorders.


Eligibility criteria:
inclusion criteria: * at least 18 years old male or female * chronic lymphoid leukaemia, any rai stage * 25-oh-vitamin-d3 level between 10 and 30 ng/ml exclusion criteria: * serum calcium \> 2,60 mmol/l * 24 hour calcium urine excretion \> 0,1 mmol/kg/day * serum phosphate \> 1,45 mmol/l * egfr \< 30 ml/min/1,73m2 * nephrolithiasis * receiving parenteral vitamin-d3 in past 6 months * activated vitamin-d3 treatment